Quantifying submission delay, deficiency rate, and remediation cost for teams that engage cybersecurity early vs. late.
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Share of submissions receiving a cybersecurity deficiency, by tier.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: % of submissions
Median days from submission filing to FDA clearance, by tier.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: days (median)
Median engineering hours required to close cybersecurity deficiencies, by tier.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: hours (median)
Per-engagement scatter of deficiency count against engagement start time.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: deficiencies
Share of submissions clearing on first review, after one round of deficiencies, or later.
Source: Blue Goat Cyber engagement dataset, 2022-2025. · Unit: % of submissions
Blue Goat Cyber. (2026). The Cost of Late Cybersecurity Engagement in MedTech. https://bluegoatcyber.com/research/cost-of-late-cybersecurity-engagement-2026
Canonical report URL: https://bluegoatcyber.com/research/cost-of-late-cybersecurity-engagement-2026